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Bridging the gap between science and science policy for better health research

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ICTR-PHE 2012 29 February 2012 jose.mariano.gago@cern.ch IRGC-International Risk Governance Council ECCO Policy Committee The Biomedical Alliance Core Group EC HLG for Health Research and Innovation IST – LIP – IP

BRIDGING THE GAP BETWEEN SCIENCE AND POLICY HEALTH RESEARCH AS A DRIVING FORCE FOR THE RENEWAL OF SCIENCE POLICIES Synopsis

Introduction The world of knowledge is changing rapidly Science Policy in Europe is at a turning point Health research as a driving force for the renewal of science policy Flashback 1 The true story of the creation of the European Research Council Flashback 2 Why we need a European Council for health research? Cancer, Physics & Medicine The 24 provocative questions on Cancer research by Harold Varmus Conclusions A Plea for Action

BRIDGING THE GAP BETWEEN SCIENCE AND POLICY

The world of knowledge is changing rapidly a larger fraction of humanity aspires to education and higher education is increasingly perceived as tomorrow’s general education in 2007: 151 M (+53% since 2000) students enrolled outside their country of origin: 0.5% in 1975, 3% in 2006 higher education has become an aspiration for all, and not exclusively for the social elites higher education is increasingly perceived as a social, economic and political driving force for progress in developing countries – providing a renewed constituency for scientific development, political democracy and justice, and for the quality of general education higher education is becoming an emerging political actor in part of the developing world science is increasingly global and increasingly perceived as linked to human, social and economic progress 2002 > 2007 5.7 > 7.1 M researchers (+25%) 780 > 1150 b US$ (+45%) 1.1 > 1.6 M publications (international cooperation: 8% in 1987, 20% in 2007) Where? Asia, Latin America, Africa major trends of change in science (policy) agendas: .Risk Governance (prevention, mitigation, response) is a new driver of science policies: natural disasters, ageing and chronic diseases, industrial and other major public risks, quality and availability of water and food, energy. .Data intensive science has spread from particle physics and astrophysics to the biological sciences. ICT and Science become closely interlinked (but: infrastructure, IPR, inequalities) . Science & Academic networking at world level: institutional networking for capacity building is becoming key; new patterns of institutional capacity building programmes are now added to the traditional fluxes of individual students.

BRIDGING THE GAP BETWEEN SCIENCE AND POLICY HEALTH RESEARCH AS A DRIVING FORCE FOR THE RENEWAL OF SCIENCE POLICY

Science Policy in Europe is at a turning point

• as it needs to respond to the fast changes in knowledge production at world level
• as it wishes to combine the response to societal challenges with increased innovation and industrial competitiveness
• (and pursue increased attractiveness for talent in S&T, while reinforcing its science base – science education, infrastructure,

…) Can the biomedical sciences provide a major driving force for the renewal of European Science Policies? Possibly yes: they have been able to develop a network of stakeholders as active (potential) participants of the research itself (researchers, clinicians, industry, patients) they have been successful in attracting contributions from other sciences and technologies (physics, engineering, social sciences) However

• how can all these stakeholders act together as producers of knowledge, namely in advanced, educated, societies?
• biomedical researchers, clinicians, patients and their families, industry have already been able to collaborate and to

contribute to the progress of research – but how can they contribute systematically to the organised production of new knowledge? (eg, patients and researchers? clinicians and researchers?) (An old problem: vd Freeman Dyson, Amateurs and Scientists; modern involvement of users in software engineering development; new trends in architecture and design…So why do we have to address it now? Because: The constituency for scientific development is not static and requires renewed participation. Complex problems increasingly require the contribution of diverse competencies and expertise, including proximity and time. Increasingly educated societies make such expertise available, as well as sensors, the internet and the availability of online and distance access to authoritative reference sources of knowledge. Multiple layers of contributors to the fabric of scientific knowledge at large scale become possible, but require renewed forms of organisation and high level scientific steering)

BRIDGING THE GAP BETWEEN SCIENCE AND POLICY HEALTH RESEARCH AS A DRIVING FORCE FOR THE RENEWAL OF SCIENCE POLICY

Flashback 1 A true story of the creation of the European Research Council (2002-2006) EU Framework Programmes for R&D: initially - industrial competitiveness only Biomedical research: a case for juridical analysis Human resources (Marie Curie) in S&T become part of the EU FP for R&D New Treaties allow for the shared responsibilities of the EU and MS in R&D In 2002-2004: Promoting the funding of basic sciences via the EU FP Programme – a grassroots movement by the scientists in Europe First response: no DK support: a seminar – Do we need a European Research Council?- and sets a working group FEBS organises a first constituency of European scientific societies and other international bodies: EUA, EPS, EMBO, EMBL,… A turning point: A EU Council for the Biomedical Sciences or for All Sciences (including the Social Sciences and Humanities)? The generosity of the biomedical community leads to the creation of the ERC ISE- Initiative For Science in Europe founded (European Societies from all disciplines). ISE organises (successfully) the first European science policy campaign by scientists (aimed at the creation of the ERC) In 2005 (2006): European Council calls for the study of the creation of a EU organisation inspired by NSF EU research (competitiveness) Council and Parliament decide the creation of the ERC as a specific delivery mechanism of FP7 EC and MS refuse the creation of a new EU organisation ERC is created as an independent scientific council and given a budget of about 2 billion Euros/yr

BRIDGING THE GAP BETWEEN SCIENCE AND POLICY HEALTH RESEARCH AS A DRIVING FORCE FOR THE RENEWAL OF SCIENCE POLICY

Flashback 2 Do we need a European Council for Health Research? ECCO - Stockholm 2011 – first discussion on the need for a EU-CHR (Set 2011) ECCO announces its commitment to the creation of a ECHR (Dec 2011) together with the Alliance for Biomedical Research The HLG on Health Research & Innovation set by the EC calls for a European Strategic Action on Health Research and supports the views of the Biomedical Alliance (Jan 2012) The EU Danish Presidency takes note of the proposal for a ECHR (Feb 2012) The Alliance for Biomedical Research establishes a Core Group to prepare actions leading to the establishment of the ECHR The European Parliament invites the Biomedical Alliance Core Group to present its views in a special meeting with MP’s

BRIDGING THE GAP BETWEEN SCIENCE AND POLICY HEALTH RESEARCH AS A DRIVING FORCE FOR THE RENEWAL OF SCIENCE POLICY

Cancer, Physics&Medicine The 24 provocative questions on Cancer research by Harold Varmus (1-12)

http://www.cancer.gov/

• PQ1. How does obesity contribute to cancer risk?
• PQ2. What environmental factors change the risk of various cancers when people move from one geographic region to

another?

• PQ3. Are there ways to objectively ascertain exposure to cancer risk using modern measurement technologies?
• PQ4. Why don't more people alter behaviors known to increase the risk of cancers?
• PQ5. Given the evidence that some drugs commonly and chronically used for other indications, such as an anti-

inflammatory drug, can protect against cancer incidence and mortality, can we determine the mechanism by which any of these drugs work?

• PQ6. What are the molecular and cellular mechanisms by which patients with certain chronic diseases have increased or

decreased risks for developing cancer, and can these connections be exploited to develop novel preventive or therapeutic strategies?

• PQ7. How does the life span of an organism affect the molecular mechanisms of cancer development and can we use our

deepening knowledge of aging to enhance prevention or treatment of cancer?

• PQ8. Why do certain mutational events promote cancer phenotypes in some tissues and not in others?
• PQ9. As genomic sequencing methods continue to identify large numbers of novel cancer mutations, how can we identify

the mutations in a given tumor that are most critical to the maintenance of its oncogenic phenotype?

• PQ10. As we improve methods to identify epigenetic changes that occur during tumor development, can we develop

approaches to discriminate between “driver” and “passenger” epigenetic events?

• PQ11. How do changes in RNA processing contribute to tumor development?
• PQ12. Given the recent discovery of the link between a polyomavirus and Merkel cell cancer, what other cancers are caused

by novel infectious agents and what are the mechanisms of tumor induction?

BRIDGING THE GAP BETWEEN SCIENCE AND POLICY HEALTH RESEARCH AS A DRIVING FORCE FOR THE RENEWAL OF SCIENCE POLICY

Cancer, Physics&Medicine The 24 provocative questions on Cancer research by Harold Varmus (13-24)

http://www.cancer.gov/

• PQ13. Can tumors be detected when they are two to three orders of magnitude smaller than those currently detected with in

vivo imaging modalities?

• PQ14. Are there definable properties of a non-malignant lesion that predict the likelihood of progression to invasive or

metastatic disease?

• PQ15. Why do second, independent cancers occur at higher rates in patients who have survived a primary cancer than in a

cancer-naïve population?

• PQ16. How do we determine the clinical significance of finding cells from a primary tumor at another site?
• PQ17. Since current methods to assess potential cancer treatments are cumbersome, expensive, and often inaccurate, can

we develop other methods to rapidly test interventions for cancer treatment or prevention?

• PQ18. Are there new technologies to inhibit traditionally “undruggable” target molecules, such as transcription factors, that

are required for the oncogenic phenotype?

• PQ19. Why are some disseminated cancers cured by chemotherapy alone?
• PQ20. Given the recent successes in cancer immunotherapy, can biomarkers or signatures be identified that can serve as

predictors or surrogates of therapeutic efficacy?

• PQ21. Given the appearance of resistance in response to cell killing therapies, can we extend survival by using approaches

that keep tumors static?

• PQ22. Why do many cancer cells die when suddenly deprived of a protein encoded by an oncogene?
• PQ23. Can we determine why some tumors evolve to aggressive malignancy after years of indolence?
• PQ24. Given the difficulty of studying metastasis, can we develop new approaches, such as engineered tissue grafts, to

investigate the biology of tumor spread?

BRIDGING THE GAP BETWEEN SCIENCE AND POLICY HEALTH RESEARCH AS A DRIVING FORCE FOR THE RENEWAL OF SCIENCE POLICY

Cancer, Physics&Medicine The 24 provocative questions on Cancer research by Harold Varmus (1-12)

(…)

• PQ3. Are there ways to objectively ascertain exposure to cancer risk using modern measurement technologies?

Background: Many methods that measure risk exposure rely on self-reporting or other survey approaches. Such surveys can be accurate in many cases, and they can be designed to increase their accuracy with good survey

• strategies. However, it would be valuable to develop more quantitative methods to record short-term or long-term

exposures with quantitative readouts. With some methods, the techniques could measure biological readouts that might be directly linked to changes associated with cancer development. Feasibility: This question calls for technological advances that can provide sensitive and accurate methods to measure exposure to agents thought to increase cancer risk. These methods might include devices to detect physical location, physical activity, exposure to carcinogenic agents, or changes in biological readouts that are altered in response to

• exposure. Detection of various small molecules by improving approaches in mass spectroscopy as well as various other

"omic"-style methodologies may be useful in these approaches. New sensors that are tuned to known carcinogens could also be used. The range of measurement goals will include, but not be limited to, detecting exogenous molecules in biological samples, recording imbalances in endogenous metabolites, following changes in epigenetic patterns, or monitoring of time and location compared to potential physical carcinogenic sites through global positioning. In addition, monitors could be tuned to measure immediate short-term exposure or cumulative longer-term exposures. Implications of success: Increasing the use of exposure measurements promises to give more accurate and quantitative values to factors that predict risk. If biological readouts are possible, the links to changes directly associated with cancer development may help speed the links between epidemiology and cancer biology.

BRIDGING THE GAP BETWEEN SCIENCE AND POLICY HEALTH RESEARCH AS A DRIVING FORCE FOR THE RENEWAL OF SCIENCE POLICY

Cancer, Physics&Medicine The 24 provocative questions on Cancer research by Harold Varmus (13-24)

• PQ13. Can tumors be detected when they are two to three orders of magnitude smaller than those currently

detected with in vivo imaging modalities? Background: Current imaging modalities allow detection of tumors composed of approximately 107 cells or in the range

• f 1 cubic millimeter. Any increase in imaging sensitivity provides valuable advances in tumor detection; however, a major

increase in detection sensitivity would provide a radical change in how we might employ imagining in clinical practice. While new advances are continually being reported and are currently the goal of NCI’s imaging grant portfolio, here we call for methods that might radically change the sensitivity of these imaging methods. Feasibility: This question calls for a huge jump in imaging sensitivity. How this increase might be achieved is left to the imagination of the community. However, one can recognize that strategies to increase sensitivity might include such approaches as matching imaging probes with biologic targets that provide some enzymatic amplification, developing much more sensitive imaging probes, or greatly improved camera sensitivity. Implications of success: The ability to detect very small clusters of cells in patients and in experimental cancer models is important from both detection and therapeutic perspectives—to find cancer at its earliest stages, to understand how and when tumors spread, to study how dissemination correlates with malignant progression, to improve strategies for treatment with precisely targeted radiation or drugs, and to monitor therapeutic responses.

BRIDGING THE GAP BETWEEN SCIENCE AND POLICY HEALTH RESEARCH AS A DRIVING FORCE FOR THE RENEWAL OF SCIENCE POLICY

Conclusions & A plea for action Scientific progress requires institutional change

A European Council for Health Research is (urgently) needed As an instrument to provide (science led) coordination of EU funding of Health research within the EC itself Bringing together Medicine, Physics and Engineering Schools (joint degrees, joint research agendas, across the EU) Attracting other fields to the opportunities of biomedical research Providing high level scientific steering and leadership across national borders Developing strategic programmes (beyond short term projects supported by individual grants) Providing scale, long term commitment, common regulatory environments, at EU level Fostering strategic international cooperation Promoting common strategic action by national and EU funding programmes, by charities and by industry Strengthening the constituency for science across Europe and fight inequalities in health care (personalised medicine) Bringing together research, industry and government in order to limit health related costs while achieving better results Social and economic progress require more science. These are times of economic uncertainty and social anxiety in Europe. However scientists and doctors benefit from the highest trust from their fellow citizens Biomedical research aims at reducing human suffering and helping each of us to live better lives and to die decently Strengthening the constituency for science and building progress upon new collaborative forms of research is needed and is becoming increasingly possible in the biomedical field. It may trigger a renewal of all science and all science policies.

J Med Genet. 2010 Jul;47(7):436-44

A few cells, isolated, so-called signet-ring cells (arrows), with mutations in a cell adhesion molecule called E-cadherin are scattered in the middle of gastric

• glands. They are already

invading and, despite they are very few, they can have metastasised already.